A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Genaera Corporation9 sites in 1 country140 target enrollmentMay 2006

ConditionsMacular Degeneration

DrugsMSI-1256F (Squalamine Lactate)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Macular Degeneration
Sponsor: Genaera Corporation
Enrollment: 140
Locations: 9
Primary Endpoint: To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
Status: Terminated
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genaera Corporation

Eligibility Criteria

Inclusion Criteria

•Adult subjects ≥ 50 years of age.
•minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
•baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
•central retinal thickness by optical coherence tomography of \> 250 microns.
•lesions \> 9 disc areas.
•\> 25% fibrosis in the lesion.

Exclusion Criteria

•Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
•retinal or optic nerve disease.
•uncontrolled diabetes.
•ongoing malignancy.

Outcomes

Primary Outcomes

To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate

Secondary Outcomes

To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography
To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography